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NCT05945290 Clinical Trial

Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:
Pre-Analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05945290
Other study ID # 19-012665
Secondary ID NCI-2022-0584419
Status Recruiting
Phase
First received
Last updated
Start date July 7, 2022
Est. completion date December 2025

Study information
Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates pre-analytical factors affecting circulating tumor deoxyribonucleic acid (ctDNA) analysis in breast cancer that not spread beyond the breast and or lymph nodes (early and locally advanced). ctDNA refers to freely circulating tumor DNA fragments found in the blood plasma. Pre-analytical factors such as blood collection tubes, delays in separation of plasma, centrifugation speeds, storage conditions, shipping and DNA extraction methods can all affect ctDNA measurements. Inappropriate processing can cause breaking down of the membrane (lysis) of peripheral blood cells that release background wild-type DNA and may also cause degradation of circulating tumor-specific DNA fragments. Both mechanisms will dilute levels of ctDNA in plasma and make it more difficult to detect. Evaluating the pre-analytical factors of the collection of blood and left over tissue samples for the research of cancer may help researchers to evaluate the impact of the blood collection/processing and long-term storage from patients with locally advanced breast cancer.

Description:

PRIMARY OBJECTIVES: I. To evaluate the impact of blood collection/processing. II. To evaluate the impact of long-term storage of plasma and extracted DNA. OUTLINE: This is an observational study. Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from standard of care (SOC) procedures and have medical records reviewed.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - All women > 18 years of age - Stage I-III breast cancer - Subject has consented to IRB 2130-00 Tissue Registry Exclusion Criteria: - Stage IV breast cancer - Unwilling or unable to give consent - Unable to participate for 1 year - No one with a concurrent cancer except those diagnosed with an in situ cancer or non-melanoma skin cancer

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo blood and leftover tissue sample collection
Other:
• Electronic Health Record Review
Medical records are reviewed

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS). Baseline to 5 years
Secondary Change in total cell-free DNA concentration Will be measured in genome copies/ml of plasma, using the Quality Assessment (QA) assay. Baseline to 5 years
Secondary Change in total cell-free DNA fragment size profile Will be measured as % fragmented, using the Quality Assessment (QA) assay. Baseline to 5 years
Secondary Change in tumor-specific circulating tumor deoxyribonucleic acid (ctDNA) fragment size profile Will be measured as average fragment size, using TARgeted DIgital Sequencing (TARDIS). Baseline to 5 years
Secondary Background error rate Will be measured as errors per bp sequenced, measured using TARgeted DIgital Sequencing (TARDIS). Baseline to 5 years
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